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Long Term Comparison of Two Different Techniques of Uterine Cesarean Incision Closure

Primary Purpose

Cesarean Section; Complications, Placenta Previa, Placenta Accreta

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Purse string closure technique
Continuously locked closure technique
Sponsored by
Dr. Lutfi Kirdar Kartal Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cesarean Section; Complications focused on measuring Cesarean section, Kerr incision, Purse string suturing in CS, Continuous locked suturing in CS

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Singleton pregnancy
  • Term (> 37 weeks) pregnancy
  • Cervical dilatation < 4 cm
  • Kerr incision
  • Age > 18 years old

Exclusion Criteria:

  • Being in active phase of labor
  • Emergency situations (fetal distress, cord prolapse, placental abruption,severe pre-eclampsia, eclampsia, placenta previa, vasa previa )
  • Having a history of uterine surgery (myomectomy, hysterotomy) other than CS
  • Extension of Kerr incision
  • Multiple pregnancy
  • Maternal diabetes mellitus
  • Maternal connective tissue disease
  • Uterine malformation
  • Uterine fibroids on Kerr incision line
  • Chorioamnionitis

Sites / Locations

  • Dr. Lütfi Kirdar Kartal Education and Research Hospital, Kartal

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Purse string closure technique

Continuously locked closure technique

Arm Description

Uterine Kerr incision will be closed with purse string suture.

Uterine Kerr incision will be closed with continuously locked closure technique.

Outcomes

Primary Outcome Measures

Placenta previa
It will be noted whether placenta previa in cesarean operation of the subsequent pregnancy within next 4 years, and two groups will be compared.

Secondary Outcome Measures

Placenta insertion anomalies
It will be noted whether placenta insertion anomalies (placenta accreta and others) in cesarean operation of the subsequent pregnancy within next 4 years, and two groups will be compared.
Uterine rupture
It will be noted whether uterine rupture (incomplete or complete, dehiscence of uterine incision) in cesarean operation of the subsequent pregnancy within next 4 years, and two groups will be compared.
Intra-abdominal adhesions
It will be noted whether intra-abdominal adhesion in cesarean operation of the subsequent pregnancy within next 4 years, and two groups will be compared.

Full Information

First Posted
February 2, 2011
Last Updated
January 20, 2016
Sponsor
Dr. Lutfi Kirdar Kartal Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01289262
Brief Title
Long Term Comparison of Two Different Techniques of Uterine Cesarean Incision Closure
Official Title
Long Term Comparison of Double Layer Continuously Locked Closure of Uterine Incision in Cesarean Section Versus Double Layer Purse String Closure (Turan Technique): A Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. Lutfi Kirdar Kartal Training and Research Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Cesarean section (C/S) is an operation most commonly performed in Obstetrics and Gynecology Clinics. Complications related with incomplete healing of Kerr uterine incision after C/S (adhesions, separation (dehiscence), endometritis, endometriosis, anomalous placentation in subsequent pregnancies, incomplete or complete uterine rupture in subsequent pregnancies, ...) are very important issues. Classically Kerr incision is repaired with continuous locked suturing. Purse string suturing of Kerr incision may reduce the size of the incision and in turn may reduce short and long term complications. For this reason, the investigators aimed to compare two closure techniques.
Detailed Description
In the clinic, patients undergoing cesarean section that meet the criteria for inclusion into the study and agreed to participate in the study will be randomized into two groups (computer-assisted randomization method will be used.) In the first group of patients classical closure method of Kerr incision(double layered continuously locked suturing) will be used. In the second group of patients double layered purse string closure technique will be used. Women will be followed for a subsequent pregnancy in the next 4 years. If they become pregnant again they will be followed up during pregnancy for comparison of long-term effects of the two suture techniques. Patients will be followed especially from the aspects of placental anomalies. Presence of intra-abdominal adhesions, uterine dehiscence, placenta previa, placental invasion anomalies (eg, placenta accreta and others)and incomplete or complete rupture will be compared between two groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section; Complications, Placenta Previa, Placenta Accreta
Keywords
Cesarean section, Kerr incision, Purse string suturing in CS, Continuous locked suturing in CS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Purse string closure technique
Arm Type
Active Comparator
Arm Description
Uterine Kerr incision will be closed with purse string suture.
Arm Title
Continuously locked closure technique
Arm Type
Active Comparator
Arm Description
Uterine Kerr incision will be closed with continuously locked closure technique.
Intervention Type
Procedure
Intervention Name(s)
Purse string closure technique
Other Intervention Name(s)
Uterine incision in C/S
Intervention Description
Uterine incision will be closed with purse string closure technique.
Intervention Type
Procedure
Intervention Name(s)
Continuously locked closure technique
Other Intervention Name(s)
Uterine incision in C/S
Intervention Description
Uterine incision will be closed with continuously locked closure technique
Primary Outcome Measure Information:
Title
Placenta previa
Description
It will be noted whether placenta previa in cesarean operation of the subsequent pregnancy within next 4 years, and two groups will be compared.
Time Frame
Subsequent pregnancy within next 4 years
Secondary Outcome Measure Information:
Title
Placenta insertion anomalies
Description
It will be noted whether placenta insertion anomalies (placenta accreta and others) in cesarean operation of the subsequent pregnancy within next 4 years, and two groups will be compared.
Time Frame
Subsequent pregnancy within 4 years
Title
Uterine rupture
Description
It will be noted whether uterine rupture (incomplete or complete, dehiscence of uterine incision) in cesarean operation of the subsequent pregnancy within next 4 years, and two groups will be compared.
Time Frame
Subsequent pregnancy within next 4 years
Title
Intra-abdominal adhesions
Description
It will be noted whether intra-abdominal adhesion in cesarean operation of the subsequent pregnancy within next 4 years, and two groups will be compared.
Time Frame
Up to 4 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Singleton pregnancy Term (> 37 weeks) pregnancy Cervical dilatation < 4 cm Kerr incision Age > 18 years old Exclusion Criteria: Being in active phase of labor Emergency situations (fetal distress, cord prolapse, placental abruption,severe pre-eclampsia, eclampsia, placenta previa, vasa previa ) Having a history of uterine surgery (myomectomy, hysterotomy) other than CS Extension of Kerr incision Multiple pregnancy Maternal diabetes mellitus Maternal connective tissue disease Uterine malformation Uterine fibroids on Kerr incision line Chorioamnionitis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasemin Karsidag
Organizational Affiliation
Dr. Lutfi Kirdar Kartal Education and Research Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Dr. Lütfi Kirdar Kartal Education and Research Hospital, Kartal
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Long Term Comparison of Two Different Techniques of Uterine Cesarean Incision Closure

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